Adhesive CapsulitisPhase 2NCT00261196
Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
A Phase 2 study testing Collagenase in people with Adhesive Capsulitis and Frozen Shoulder, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adhesive Capsulitis, Frozen Shoulder
- What is being tested?
- Collagenase
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of frozen shoulder of at least one month duration
Who cannot join
- shoulder arthritis
- rotator cuff tears
- any chronic, serious, uncontrolled medical condition
- inability to conform to study visits (20-30 per year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. Orthopaedics, SUNY@Stony Brook
Stony Brook, New York, 11794
About this study
The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.
Read the detailed description
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).
Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Being tested
- Collagenase
- Keywords
- Frozen Shoulder
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagenaseDrug
Also called Xiaflex
Anterior shoulder capsule injection
| Study group | Role | What they receive |
|---|---|---|
| Collagenase | Experimental | Collagenase Injection Receives: Drug: Collagenase |
| Placebo | Placebo comparator | Placebo Injection Receives: Drug: Collagenase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active elevation of the affected shoulder
Active Elevation in degrees by goniometer measurement
Measured: 30 days
Secondary outcomes (1)
Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.
Active and passive internal/external rotation in degrees by goniometer measure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: IND moved to sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Badalamente, Stony Brook University
- Investigators
- Marie A Badalamente, PhD, Principal investigator, Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261196
- Sponsor's protocol ID
- Shoulder 202
- Status last verified
- Oct 2019
- First submitted
- 30 Nov 2005
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
- ClinicalTrials.gov ID
- NCT00261196
- Acronym / sponsor ID
- Shoulder 202
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Keywords
- Frozen Shoulder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IND moved to sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.
Detailed description
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).
Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase | Experimental | Drug: CollagenaseCollagenase Injection |
| Placebo | Placebo comparator | Drug: CollagenasePlacebo Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of frozen shoulder of at least one month duration
Key exclusion criteria (4 listed)
- shoulder arthritis
- rotator cuff tears
- any chronic, serious, uncontrolled medical condition
- inability to conform to study visits (20-30 per year)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CollagenaseAlso: XiaflexAnterior shoulder capsule injection | Drug | Collagenase, Placebo |
Primary outcome
Active elevation of the affected shoulder
Time frame: 30 days
Active Elevation in degrees by goniometer measurement
1 secondary outcome
Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie A Badalamente, PhD principal investigator
Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collagenase in people with Adhesive Capsulitis and Frozen Shoulder, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active elevation of the affected shoulder (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.